Embodiments of the invention relate to the field of medical devices and more particularly to solid elastomers applied to an area of discomfort for purposes of heating or cooling the area, providing compression to the area, aerating the area, and/or providing padding to the area. No existing device provides such a combination of affects to provide optimal functionality and use for the wearer.
It is commonplace for people to utilize devices with thermal capacitance to treat an injury or area of discomfort. A hot-cold pack is an example of one such widely utilized device. Cold packs are generally used in order to numb an area and relieve swelling, while hot packs are used to loosen up tight muscles or tendon strains. Many hot-cold packs utilize a gelatinous substance that can undergo state changes in order to provide a higher capacity of heat absorption, i.e., cooling. Such gels may provide similar functionality using water or chemical compounds that initiate changes in state (i.e., liquid to solid). A majority of hot-cold packs and other similar devices store the gel or liquid based substance that provides thermal capacitance in a sealed bag. A problem with this approach is that over time, these bags often leak or otherwise degrade to a point where use is impractical.
Another issue with using current hot-cold packs is that problems can arise when the treatment area receives little air, as the underlying area can become sweaty and the hot-cold pack can laterally or vertically slide around on the treatment area during movement of the recipient. Thus, in some instances application of the hot-cold pack can further aggravate the injury, or frustrate the wearer to the point of not using the hot-cold pack.
Existing hot-cold packs are designed for use on immobile subjects and generally lack an effective securing mechanism. When the subject of the hot-cold pack treatment is an athlete, animal or a young child or any other entity requiring continued mobility, it is important to adequately secure the pack to the subject. Securing the hot-cold packs is typically achieved by a secondary means. Generally, the packs are held in place with an elastic bandage which limits the mobility of movement of recipient of the pack since the pack may easily become displaced and fall off. In other instances, the packs are held in place within a pouch that acts as a means for immobilizing and securing the pouch to a subject, however the packs are still heavy and even if secured tightly still inhibit mobility due to their weight and thickness.
In certain instances it is desirable to compress the hot-cold pack against the region of treatment. Current hot-cold packs lack the elasticity required to perform such compression. It is, however, possible to use a secondary means, namely by an elastic bandage wound around the hot-cold pack, to compress the hot-cold pack against the region to be treated. Thus, some compression type inventions require a secondary device in order to use the hot-cold pack. This is inconvenient in that a person wishing to apply the hot-cold pack to an area for treatment is required to utilize two items before application of the hot-cold pack can occur. In addition, the elastic properties of straps are known to degrade over time, resulting in a poor compression as the age of the strap increases.
The bandage described in U.S. Pat. No. 5,160,328, filed Nov. 3, 1992 to Cartmell, et al., entitled “Hydrogel bandage” consists of a self-adhesive bandage including a substrate having a two sides and multiple layers including a backing layer which forms the first side of the substrate, and an adhesive layer which forms the second side of the substrate. A hydrogel layer is disposed over the second side of the substrate and is made from a polyurethane hydrogel material for absorbing bodily fluids, including wound exudate. Multiple support layers may be interposed between the substrate and the hydrogel layer to provide the bandage with additional support. Although lightweight, and providing a means for aerating a wound, the bandage is incapable of providing compressive means to bear on the wound since the adhesive layer locks the bandage in place over a treatment area.
The bandage described in U.S. Pat. No. 5,531,670, filed Jul. 2, 1996 to Westby, et al., entitled “Heat Conserving Bandage” consists of a heat conserving bandage to cover human or animal tissue, comprising heat reflecting means, positioned next to the tissue for reflecting heat from the tissue, insulation material means covering said heat reflecting means, and cloth covering the insulation material. The heat reflecting means includes a sandwiched structure of a foil of plastic material adjacent to the tissue, and a second foil bonded thereto. Further cloth means can be inserted between the heat reflecting means the tissue. Suitably, the cloth means and the heat reflecting means are bonded together by sewing or an adhesive to create a pocket for receiving the insulation material. Although lightweight and flexible, the invention described provides no means for aerating the treatment area, and indeed attempts not to aerate a treatment area since it is providing a means to insulate only, and not add or remove heat.
The compress described in U.S. Pat. 4,556,055, filed Dec. 3, 1985 to Bonner, entitled “Cold Compress”, consists of a bandage defined by a layer of closed cell foam polymeric material sandwiched between and bonded to adjacent layers of fabric. One of the layers of fabric is absorbent with respect to aqueous liquids, such as wound exudate, and is adapted to be in contact with an area of the body. Multiple straps are releasably attached to the bandage to form a compress. The straps facilitate adjustment of the compress, the compress also may possess elongated pockets sewn to the fabric layer opposite the absorbent layer for insertion of straps to form a brace or provide for additional cooling. Electrodes are contemplated for providing electrical stimulation. Although allowing for application of a cold pad on a treatment area with a compress, the invention is heavy, thus compromising mobility, and is cloth wrapped in order to absorb aqueous fluids. The bandage also allows for electrical stimulation.
The pad described in U.S. Pat. No. 4,588,400, filed May 13, 1986 to Ring, et al., entitled “Liquid loaded pad for medical applications”, consists of wound and burn dressings which are prepared from pellicles, which are a thin film of microbially-produced cellulose obtained, for example, by culturing Acetobacter xylinum. A pellicle having a thickness from about 0.1 to 15 millimeters or greater is processed to replace the culture medium with water or other physiologically compatible liquid. The liquid-loaded pellicle is sterilized prior to its use as a dressing or in other medical applications. The pad is liquid based, is heavy, and therefore does not allow for complete mobility or direct aeration. It also appears to be directed towards immobile burn victims, hence it is not designed to provide a compressive means.
The therapeutic cooling device described in U.S. Patent Application 20020103520, filed Aug. 1 ,2002 to Latham, entitled “Therapeutic cooling devices”, consists of a thermal regulatory system to reduce swelling caused by trauma to a variety of tissues and limbs. One or more substantially flexible, at least partially thermally conductive housings containing an activatable thermal regulatory medium may be coupled with one or more applicator, such as a splint, that is adapted to apply the thermal source to the tissue. The invention also discloses methods of therapeutically regulating tissue temperature. The invention relates to thermal regulatory systems that are generally heavy gel filled devices that are form fitted for a particular body part not allowing mobility, and providing no means for compressing a treatment area.
The therapeutic pack described in U.S. Pat. No. 5,190,033, filed May 2, 1993 to Johnson, entitled “Ice peas cold/hot therapeutic pack”, consists of an improved cold/hot pack for physiotherapy having a completely sealed flexible pouch. The cavity of the pouch is filled with a plurality of approximately pea sized or larger hollow capsules. The cavities of the hollow capsules are filled with cold/hot storing fluid or gel and are essentially used as a replacement for frozen peas. Partitions prevent migration of the capsules within the pouch and a screened plug permits air to be expelled from the pouch while the capsules are retained in order to conform the pouch to a given body part. The invention appears to be flexible but contains capsules in a pouch that would inhibit mobility when the pouch was strapped on. In addition, the invention would not allow the underlying treatment area to be aerated. The invention appears have no means for applying a compressive force and is directed mainly to cooling of the treatment area solely in a manner mirroring the use of frozen vegetable bags.
The therapeutic device described in U.S. Pat. 4,592,358, filed Jun. 3, 1986 to Westplate, entitled “Therapeutic device”, consists of a therapeutic device featuring a plurality of compartments enclosing a therapeutic substance such as a refrigerant material which remains a liquid or forms a slush at temperatures below about 0 degree Celsius, or a heat releasing substance, or a high density material which may be firmly positioned on various body portions using one or more strap means. The invention does not allow for aeration of an underlying treatment area, and uses liquid in order to cool, or a high density material to heat. Each mode of use would not allow for mobility or compression since the device provides non-elastic straps for fastening the device. The device can not be cut or formed into a shape other than that supplied.
The compress described in U.S. Pat. No. 5,697,961, filed Dec. 16, 1997 to Kiamil, entitled “Compress for use in cold and/or hot treatment of an injury”, consists of a compress suitable for use in hot and cold treatments of an animal or human body part, comprising a flexible container containing a formulation comprising an aqueous solution and discrete particles of a crosslinked, water-absorbing polymer. In one embodiment, the compress is contained in a sealed plastic bag. The formulation used in the compress can be an anti-freeze agent, a salt compound, a glycol compound or mixtures thereof. The crosslinked, water-absorbing polymer in one embodiment is polyacrylamide or sodium polyacrylate. The invention applies a compressive force to a treatment area, but does not allow for aeration, is heavy, can require an external heat storage unit attached to the compress and is therefore unable to provide mobility. In addition the device cannot be cut to fit a treatment area.
The bandage described in U.S. Pat. No. 5,431,622, filed Jul. 11, 1995 to Pyrozyk et al., entitled “Thermal bandage”, consists of a thermal bandage apparatus for simultaneously dressing and thermally treating a wounded area. The device includes a fluid absorbent member having a wound contacting surface for absorbing bodily fluids produced by an open wound and a holding means adjacent and connected to the fluid absorbent member for holding a thermal medium against the fluid absorbent member such that heat is transferred between the thermal medium and the open wound by thermal conduction through the fluid absorbent member. There is also disclosure of an arrangement for providing a continuous supply of heat or cold to a wound. The invention is a non-aerating, and fluid absorbing bandage with associated thermal source pump attached or pouches for the insertion of gel bags. The invention, therefore, does not allow for mobility, aeration or compression.
The bandage described in U.S. Pat. No. 5,887,437, filed Mar. 30, 1999 to Maxim, entitled “Self-adhering cold pack”, consists of a self-adhering cold pack having an envelope defining a sealed cold pack volume. A cooling agent is positioned in the cold pack volume. A bandage sheet is fixed to the envelope by a bandage adhesive. The bandage sheet defines mounting tabs linearly extending from the envelope outer perimeter in order to support a bandage adhesive for temporary adhesion of the cold pack to the skin surface of a patient. The invention does not allow for aeration, is heavy and would not allow for compression of the treatment area.
The bandage described in U.S. Pat. No. 6,528,696 filed Mar. 4, 2003, to Ireland, entitled “Pliable contact bandage”, consists of a pliable contact bandage for placement over a wound site located on any skin surface. The apparatus includes a re-openable, flexible enclosure adapted to receive a source of heat or cold, and an adhesive for mounting the pliable contact bandage on a skin surface. The source of heat or cold is temporarily placed within the flexible enclosure and the pliable contact bandage is placed over the wound site in a heat conducting relationship. Typically, a hypo-allergenic adhesive is located along at least a portion of the periphery of the flexible enclosure. The periphery of the flexible enclosure surrounds the wound site. There is no attempt made at enabling mobility or aeration, or compression of the treatment area.
The elastomer described in U.S. Pat. No. 5,334,646, filed Aug. 2, 1994, to Chen, entitled “Thermoplastic elastomer gelatinous articles”, consists of novel gelatinous compositions and articles formed from an intimate melt blend admixture of poly(styrene-ethylene-butylene-styrene) triblock copolymer and high levels of a plasticizing oil. The gelatinous composition is transparent and has properties including unexpectedly high elongation and tensile strength and excellent shape retention after extreme deformation under high-velocity impact and stress conditions. The gelatinous products of this invention are soft, flexible, and have elastic memory, characterized by a gel rigidity of from about 20 gram to about 700 gram Bloom. The invention is an elastomer and articles of manufacture based on the gelatinous elastomer. The patent however does not enable the creation of an aerating, mobile embodiment, or enable the manufacture of an embodiment with additives allowing for higher heat capacity.
The elastomer described in U.S. Pat. No. 5,994,450, filed Nov. 30, 1999, to Pearce, entitled “Gelatinous elastomer and methods of making and using the same and articles made therefrom”consists of gelatinous elastomers, methods for making gelatinous elastomers, methods for using gelatinous elastomers, products made from gelatinous elastomers, and products which include gelatinous elastomers as a component or ingredient. More particularly, the invention includes a gelatinous elastomer formed from a combination of a block copolymer of the general configuration A-B-A and a plasticizer. The preferred A-B-A copolymer of the invention is polystyrene-hydrogenated poly(isoprene+butadiene)-polystyrene and the preferred plasticizer is either mineral oil or a combination of mineral oil and resin. Various other components may be included in the preferred recipes according to the invention. This invention includes improvements to Chen's '646 invention, but does not enable the construction of a lightweight, aerating, mobile, compressive bandage.
Because of the problems associated with current systems, there is a need for an improved bandage that adequately overcomes the limitations existent in the prior art.